Cardiovascular Diseases, Coronary Artery Disease
Conditions
Keywords
Drug Eluting Stent, Interventional Cardiology, Percutaneous Coronary Intervention
Brief summary
The primary objective of the RESOLUTE international registry is to document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a 'real-world' patient population requiring stent implantation.
Detailed description
As part of the broader clinical program of the Resolute stent, the RESOLUTE International registry will expand the experience and understanding of the device performance in a 'real-world' setting. The registry intends to enroll patients from a large number of centers under commercial usage conditions, with the aim to reflect 'real-world' usage as much as possible.
Interventions
DEVICEEndeavor Resolute Zotarolimus-Eluting Coronary Stent System
Stent implantation
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Vascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum legal age (18) * Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines * Patient has consented to participate and authorized in writing the collection and release of medical information * Elective use of the Endeavor Resolute stent
Exclusion criteria
* Pregnancy * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Currently participating in another trial preventing routine hospital treatment * Previous enrollment in the RESOLUTE International registry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel) | 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition | 12 Months |
Countries
Germany
Participant flow
Recruitment details
Start recruitment: August 28, 2008 \> End recruitment: March 19, 2009
Participants by arm
| Arm | Count |
|---|---|
| Resolute Drug-Eluting Stent | 2,349 |
| Total | 2,349 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Resolute Drug-Eluting Stent |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1089 Participants |
| Age, Categorical Between 18 and 65 years | 1260 Participants |
| Age Continuous | 63.5 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment Argentina | 17 participants |
| Region of Enrollment Europe | 2118 participants |
| Region of Enrollment India | 174 participants |
| Region of Enrollment South Africa | 40 participants |
| Sex: Female, Male Female | 521 Participants |
| Sex: Female, Male Male | 1828 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,334 |
| serious Total, serious adverse events | 33 / 2,334 |
Outcome results
Primary
Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)
Time frame: 12 Months
Population: Analysis per intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Death or Target Vessel MI | Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel) | 4.2 percentage of participants |
Secondary
Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition
Time frame: 12 Months
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Death or Target Vessel MI | Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition | 0.9 percentage of participants |